計劃書編號1305-0031
NCT Number(ClinicalTrials.gov Identfier)NCT06238622
試驗執行中
2024-07-01 - 2027-11-28
Phase III
尚未開始1
召募中7
ICD-10J84.10
肺部纖維化
ICD-10J84.112
特發性肺部纖維化
ICD-10J84.114
急性間質性肺炎
ICD-10J98.19
肺塌陷
ICD-9516.3
原發性纖維性肺泡炎
一項開放性延伸試驗，旨在評估口服 BI 1015550 對特發性肺纖維化 (IPF) 和漸進性肺纖維化 (PPF) 患者的長期安全性和療效 (FIBRONEER™-ON)
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試驗申請者
台灣百靈佳殷格翰股份有限公司
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試驗委託 / 贊助單位名稱
台灣百靈佳殷格翰股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/04/24
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 尚未開始
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
特發性肺纖維化 (IPF) 和漸進性肺纖維化 (PPF)
試驗目的
本試驗的目的是了解肺纖維化患者對 BI 1015550 的長期耐受性。本試驗還檢測 BI 1015550 是否可以改善受試者的肺功能以及改善症狀。
藥品名稱
錠劑
主成份
0400000100
0400000100
0400000100
劑型
110
劑量
9 mg/Film-coated tablets
18 mg/Film-coated tablets
18 mg/Film-coated tablets
評估指標
主要療效指標為患者在延伸試驗過程中是否發生任何不良事件（是/否）。
主要納入條件
1. 完成母試驗（1305-0014 或 1305-0023）治療且根據試驗計畫書未提前永久停止治療的患者（即在有或沒有暫時中斷治療的情況下完成治療）
2. 獲准進入本試驗前，根據國際醫藥法規協和會之藥品優良臨床試驗規範 (ICH-GCP) 和當地法律簽署書面受試者同意書並註明日期
3. 具生育能力的女性 (WOCBP) 必須願意且能夠依據國際醫藥法規協和會 (ICH) M3 (R2) 準則持續且正確使用失敗率低於每年 1%的高度有效的避孕方法。。具生育能力的婦女(WOCBP)即使服用口服避孕藥 (OCs) 還必須確保在與伴侶進行性行為時使用一種屏障方法，例如保險套，以因應可能因嚴重嘔吐和腹瀉而降低 OCs 療效之風險的情況。符合這些條件的避孕方法清單以及關於其使用持續時間的說明，見於主受試者同意書中「避孕資訊」章節的參與者資訊。
2. 獲准進入本試驗前，根據國際醫藥法規協和會之藥品優良臨床試驗規範 (ICH-GCP) 和當地法律簽署書面受試者同意書並註明日期
3. 具生育能力的女性 (WOCBP) 必須願意且能夠依據國際醫藥法規協和會 (ICH) M3 (R2) 準則持續且正確使用失敗率低於每年 1%的高度有效的避孕方法。。具生育能力的婦女(WOCBP)即使服用口服避孕藥 (OCs) 還必須確保在與伴侶進行性行為時使用一種屏障方法，例如保險套，以因應可能因嚴重嘔吐和腹瀉而降低 OCs 療效之風險的情況。符合這些條件的避孕方法清單以及關於其使用持續時間的說明，見於主受試者同意書中「避孕資訊」章節的參與者資訊。
主要排除條件
Exclusion Criteria:
Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
Patient will undergo lung transplantation, with an assigned date of surgery.
Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
Patient will undergo lung transplantation, with an assigned date of surgery.
Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional, unexplained and clinically significant (>10%) weight loss during the parent trial
At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
試驗計畫預計收納受試者人數
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台灣人數
50 人
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全球人數
1700 人
